Creating and maintaining functional residual capacity in preterm neonates with Respiratory Distress Syndrome (RDS)

ISRCTN	ISRCTN12757724
DOI	https://doi.org/10.1186/ISRCTN12757724
Protocol serial number	N/A
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	Leiden University Medical Centre (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Arjan B. Pas, te
Scientific

Department of Pediatrics, Leiden University Medical Center, J6-S, P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5262909
Email	a.b.te_pas@lumc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EFURCI
Study objectives	A sustained inflation with a mechanical device and early nasal continuous positive airway pressure is a more effective management strategy for RDS in preterm infants than conventional intervention with a self-inflating mask and bag, and reduces the requirement for mechanical ventilation and surfactant treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory Distress Syndrome, Preterm neonates
Intervention	Resuscitation at birth when necessary: Group A: Prolonged inflation of 10 seconds with a mechanical device (Neopuff t-piece resuscitator) and early CPAP treatment. Group B: Inflation with self-inflating mask and bag conform international resuscitation guidelines.
Intervention type	Other
Primary outcome measure(s)	Need of endotracheal intubation within 3 days after birth.
Key secondary outcome measure(s)	1. Death 2. Bronchopulmonary Dysplasia (BPD)
Completion date	01/07/2007

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	1. Preterm neonates 2. Gestational age range 25 - 32 weeks (more than 24 weeks and 6 days and not more than 32 weeks and 6 days)
Key exclusion criteria	Antenatal diagnosed congenital anomalies of the cardio or respiratory system or anomalies incompatible with survival.
Date of first enrolment	01/04/2005
Date of final enrolment	01/07/2007

Department of Pediatrics, Leiden University Medical Center, J6-S, P.O. Box 9600

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/08/2007		Yes	No